NCT00728936

Brief Summary

First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2007

Typical duration for phase_1

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

August 1, 2008

Results QC Date

November 28, 2017

Last Update Submit

September 28, 2018

Conditions

Hepatitis C

Keywords

Hepatitis Cunresponsive to pegylated interferon and ribavirin therapyhepatitis C virus

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Safety.

    Count and percentage of subjects with treatment emergent adverse events

    From screening through study completion, 86 to 115 days in total

Study Arms (7)

IMO-2125 0.04 mg/kg q week

EXPERIMENTAL

IMO-2125 given weekly at 0.04 mg/kg

Drug: IMO-2125

IMO-2125 0.08 mg/kg q week

EXPERIMENTAL

IMO-2125 given weekly at 0.08 mg/kg

Drug: IMO-2125

IMO-2125 0.16 mg/kg q week

EXPERIMENTAL

IMO-2125 given weekly at 0.16 mg/kg

Drug: IMO-2125

IMO-2125 0.32 mg/kg q week

EXPERIMENTAL

IMO-2125 given weekly at 0.32 mg/kg

Drug: IMO-2125

IMO-2125 0.48 mg/kg q week

EXPERIMENTAL

IMO-2125 given weekly at 0.48 mg/kg

Drug: IMO-2125

Placebo

PLACEBO COMPARATOR

Weekly saline placebo

Drug: Saline placebo

IMO-2125 0.16 mg/kg twice a week

EXPERIMENTAL

IMO-2125 given twice a week at 0.16 mg/kg

Drug: IMO-2125

Interventions

IMO-2125DRUG

IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

IMO-2125 0.04 mg/kg q weekIMO-2125 0.08 mg/kg q weekIMO-2125 0.16 mg/kg q weekIMO-2125 0.16 mg/kg twice a weekIMO-2125 0.32 mg/kg q weekIMO-2125 0.48 mg/kg q week
Saline placeboDRUG

saline placebo given subcutaneously

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCV-positive
  • Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin

You may not qualify if:

  • Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)
  • Inadequate bone marrow, liver, and renal function
  • Treatment with any IFN (interferon)-based or other experimental or antiviral therapies within 30 days
  • Other significant medical diseases
  • Known alcohol or drug abuse within the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Gastoenterstinal Specialist of Georgia, PA

Marietta, Georgia, 30060, United States

Location

Henry Ford Med Ctr- Columbus

Novi, Michigan, 48377, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

The Liver Institute

Dallas, Texas, 75203, United States

Location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

Fundacion de Investigacion de Diego

Santurce, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

tilsotolimod

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Idera Medical Monitor
Organization
Idera Pharmaceuticals, Inc
clinicaltrials@iderapharma.com
617-679-5500

Study Officials

  • Alice Bexon, MD

    Idera Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 6, 2008

Study Start

September 1, 2007

Primary Completion

December 1, 2009

Study Completion

May 1, 2010

Last Updated

February 15, 2019

Results First Posted

February 15, 2019

Record last verified: 2017-11

Locations

US(6)PR(1)